MOTAAR: Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05395598
Collaborator
Santelys Association (Other), Région Nord-Pas de Calais, France (Other), Association de Cardiologie Nord-Pas de Calais (Other)
320
84

Study Details

Study Description

Brief Summary

Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Different factors are supposed to increase the risk of aortic enlargement as high blood pressure and sleep disorder breathing. The modality of imaging and clinical follow-up are well defined. In this prospective observational study, the aim to assess the incidence of of major complications during follow-up in a population of patients with a small or moderate thoracic aneurysm. The study will also try to identify systemic factors influencing aneurysm evolution.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    320 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2029
    Anticipated Study Completion Date :
    Oct 1, 2029

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence within 5 years of inclusion of a major aortic even [during the 5 years after inclusion]

      This composite end point is defined as the occurrence of: Aneurysm-related death Emergency surgery for threatened aortic rupture or aortic dissection Scheduled surgery for aneurysmal dilatation of more than 5 mm over 1 year Aneurysm progression exceeding 55 mm in diameter Root surgery for management of symptomatic aortic valve disease (insufficiency or narrowing) of high grade defined by tight aortic narrowing (V Max≥4 m/s, mean gradient ≥40mmHg, and area ≤1cm² or severe aortic insufficiency (regurgitated volume≥60 ml, shortening fraction≥ 50%.

    Secondary Outcome Measures

    1. Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement [during the 2 years after inclusion]

      The blood pressure measurement (averaged over 24 h)<130/80 mmHg and nocturnal blood pressure ≤120/70 mmHg

    2. Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index [during the 2 years after inclusion]

      for Apnea Hypopnea Index = ≥5 events per hour for Oxygen Desaturation Index = ≥5 events per hour

    3. Occurrence during the 5 years after inclusion of a major cardiovascular event [during the 5 years after inclusion]

      This composite criterion is defined by the occurrence of death from cardiovascular causes, myocardial infarction, stroke (ischemic or hemorrhagic), or hospitalization for heart failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Documentation of an aortic root aneurysm > 40 mm

    • Agreement to participate to a longitudinal study and available for a 5 years follow-up

    Exclusion Criteria:
    • Presence of comorbidities or pathology with a prognosis of less than 1 year

    • Personal or family history of genetically documented elastic tissue disease or patient meeting the GAND clinical criteria suggestive of Marfan disease

    • High-grade mitra-aortic valve disease, even if asymptomatic

    • Unbalanced hypertension ≥ 180/110 mmHg

    • Aneurysm (regardless of thoracic or abdominal location) ≥ 50 mm

    • Aneurysm (regardless of thoracic or abdominal location) with documented progression of more than 5 mm over one year

    • History of aortic surgery or endovascular intervention and history of type B aortic dissection of medical treatment

    • Renal insufficiency on dialysis, or GFR< 30 ml/mn (CKD-EPI)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille
    • Santelys Association
    • Région Nord-Pas de Calais, France
    • Association de Cardiologie Nord-Pas de Calais

    Investigators

    • Principal Investigator: Pascal DELSART, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05395598
    Other Study ID Numbers:
    • 2021_0151
    • 2022-A00439-34
    First Posted:
    May 27, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2022